CAM Procedure with BMAC for Shoulder OA

Phase 1

Recruiting

• Conditions: Shoulder Osteoarthritis
• Interventions: Biological: Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure.

• Registration Number: NCT04826224
• Lead Sponsor: Shane A. Shapiro

Brief Summary

Researchers want to find out more about the side effects of Bone Marrow Aspirate Concentrate (BMAC) and what doses of BMAC are safe for people.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Study Start: 2021-12-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with Osteoarthritis of the shoulders	Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure.	Subjects diagnosed with Osteoarthritis of the shoulders will be injected with concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure.

Primary Outcome Measures

Name	Time	Method
Morbidity related to bone marrow aspirations from iliac crests	1-3 Weeks Post-Procedure	Occurrence of adverse reactions to bone marrow aspirations from iliac crests
Adverse Reactions	1-3 Weeks Post-Procedure	Occurrence of adverse reactions to BMAC when delivered after shoulder CAM procedure

Secondary Outcome Measures

Name	Time	Method
Change in range of motion	Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery	Measured in degrees
Change in Visual Analog Scale (VAS)	Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery	Measured using the VAS questionnaire: a validated, subjective measure for pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain" (10).
Change in American Shoulder and Elbow Surgeons Shoulder Score (ASES)	Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery.	Measured using the self-reported ASES questionnaire that combines pain and activities of daily living (ADL) scores for a total score out of 100, where a higher score indicates a better outcome.
Change in Subjective Shoulder Value	Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery	Subjective Shoulder Value (SSV) is a single-item self-completed measure in which patients are asked to grade their shoulder as a percentage of an entirely normal shoulder, which would score 100%.
To collect and explore pre and post injection measures of cartilage status in the affected shoulder.	12 Months	Assessment of structural changes of the shoulder on conventional radiographs including measurement of inferior humeral osteophyte and joint space width

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States